23 March 2017
New EASAC report on genome editing advises European policy-makers on how to approach groundbreaking research on plants, animals, microbes and humans
A new report by the European Academies’ Science Advisory Council on genome editing gives advice to European policy-makers on groundbreaking research involving genome editing and plants, animals, microbes and patients. In this report, “Genome Editing: Scientific opportunities, public interests, and policy options in the EU”, EASAC emphasises that policy-makers must ensure that the regulation of applications is evidence-based, takes into account likely benefits as well as hypothetical risks, and is proportionate and sufficiently flexible to cope with future advances in the science.
Present knowledge gaps and uncertainties mean that more basic research will be necessary. EASAC expects that research advances will fill many of the current knowledge gaps and that progressive refinement of genome editing tools will further increase their efficiency and specificity, thereby reducing off-target effects. EASAC anticipates that the fast pace of change in research and innovation will continue.
EASAC’s new report addresses several areas in which genome editing occurs, including plants, animals, micro-organisms, human cell genome editing as well as gene drive applications for vector control. EASAC also makes recommendations regarding cross-cutting issues, including engaging with the public.
A few highlights from EASAC’s conclusions include:
•Regarding plants, EASAC advises EU regulators to regulate the specific agricultural trait/product rather than the technology by which it is produced.
•As genome editing pertains to animals, livestock breeding in agriculture should also be governed by the same principle as proposed for plant breeding – to regulate the trait rather than the technology and be open and explicit about what is being done.
•With regard to the modification of animals to serve as a source for xenotransplantation, EASAC urges European regulators to prepare for the new opportunities coming into range.
•For gene drive applications, for example to help in control of disease vectors, EASAC supports proposals for a phased approach to research that will enable responsible development and allow sufficient time to consider what changes might be needed in regulatory frameworks.
•Genome editing in microbes does not raise new issues for regulatory frameworks and is currently subject to the established rules for contained use and deliberate release of GMOs. Given the wide range of potential applications, including pharmaceuticals and other high value chemicals, biofuels, biosensors, bioremediation and the food chain, it is important to consider these in the EU strategy for innovation in the bioeconomy.
•Regarding human cell genome editing, intensive basic and clinical research is needed and should proceed subject to appropriate legal and ethical rules and standardised practices. Clinical use of somatic cell gene editing should be rigorously evaluated within existing and evolving regulatory frameworks. Clinical use of germline interventions (that would be heritable) poses difficult issues and it would be irresponsible to proceed until and unless the relevant scientific, ethical, safety and efficacy issues have been resolved and there is broad societal consensus.
EASAC urges the policy community as well as scientists to continue their efforts to promote public engagement with the important research advances and their societal implications. It is important for both policy-makers and scientists to build trust with the public. Public engagement will also require greater investment in social science to better understand how to improve.
Global justice is also a crucial element to consider. There may be risk of increasing inequity and tension between those who have access to the benefits of genome editing applications and those who do not, although the widespread adoption of the technique might facilitate the sharing of benefits. It is also vital for EU policy-makers to appreciate the consequences, sometimes inadvertent, of EU policy decisions on those outside the EU.
Read the EASAC report here.
EASAC is formed by the national science academies of the EU Member States, Norway and Switzerland, to collaborate in giving advice to European policy-makers. EASAC provides a means for the collective voice of European science to be heard. Through EASAC, the academies work together to provide independent, expert, evidence-based advice about the scientific aspects of European policies to those who make or influence policy within the European institutions.
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Notes to Editors
Please find below the full text of EASAC’s recommendations regarding genome editing.
EASAC’s recommendations to the EU are as follows:
The increasing precision now possible in plant breeding represents a big change from conventional breeding approaches relying on random, uncontrolled chemical or radiation induced mutagenesis and meiotic recombination. In supporting the conclusions from previous EASAC work on new plant breeding techniques:
•EU regulators should confirm that the products of genome editing, when they do not contain DNA from an unrelated organism, do not fall within the scope of GMO legislation.
•There should be full transparency in disclosing the process used, but the aim in the EU should be to regulate the specific agricultural trait/product rather than the technology by which it is produced. It follows that new technologies would be excluded from regulation if the genetic changes they produce are similar to, or indistinguishable from, the product of conventional breeding and if no novel, product-based risk is identified.
Research on animals is already subject to stringent regulation. While most genome-edited animals are currently being generated for basic or biomedical research, the technology also provides opportunities for livestock and aquaculture. It should be appreciated that in addition to potential increases in production, genome editing brings possibilities to enhance animal health and welfare. With regard to specific applications:
•Livestock breeding in agriculture should also be governed by the same principle as proposed for plant breeding – to regulate the trait rather than the technology and be open and explicit about what is being done.
•With regard to the modification of large animals to serve as a source for xenotransplantation, EASAC urges EU regulators to prepare for the new opportunities coming into range: this may require further discussion of the mechanism for approving medical products relating to cells and tissues, together with assessment of the implications of whether the edited donor, in the absence of additional transgenes, is regarded as a GMO or not.
Gene drive to modify populations in the wild
Gene drive applications for vector control and other modifications of target populations in the wild offer significant potential opportunities to help address major public health and conservation challenges. As outlined recently by the US National Academies, a phased approach to research can enable responsible development and offers sufficient time for considering what amendments are needed to current regulatory frameworks to enable the sound evaluation of a gene-drive based technology. EASAC supports the recommendations by the US National Academies on gene drive approaches:
•It is essential to continue the commitment to phased research to assess the efficacy and safety of gene drives before it can be decided whether or not they will be suitable for use.
•This research must include robust risk assessment and public engagement.
•EU researchers must continue to engage with researchers and stakeholders in the countries where gene drive systems are most likely to be applied.
•Genome editing in microbes does not raise new issues for regulatory frameworks and is currently subject to the established rules for contained use and deliberate release of GMOs.
•There is a wide range of potential applications, including pharmaceuticals and other high value chemicals, biofuels, biosensors, bioremediation and the food chain. It is important to recognise this wide range when developing EU strategy for innovation in the bioeconomy.
•Many of the policy issues for microbial genome editing research and innovation fall within the scope of what is regarded as synthetic biology, and we reaffirm the general recommendations from previous EASAC work relating to building research capacity, promoting skills development and recognising the need to achieve a balance between protection of innovation and benefit-sharing.
•Concerns have been raised elsewhere about the possibility for genome editing research to be conducted outside of regulated laboratory settings. We recommend that the Global Young Academy should assess the issues raised by the expansion of the Do-It-Yourself biology community.
•Concerns have also been expressed elsewhere about the potential biosecurity implications of genome editing. We recommend that the scientific community continues to inform and advise policy-makers during review of the Biological and Toxins Weapon Convention.
Human cell genome editing
EASAC endorses the emerging conclusions from other collective academy work (International Summit on Gene Editing and FEAM) and the initiatives of EASAC member academies:
•Basic and clinical research: Intensive research is needed and should proceed subject to appropriate legal and ethical rules and standardised practices. If, in the process of research, early human embryos or germline cells undergo genome editing, the modified cells should not be used to establish a pregnancy. EASAC recognises that the decision by the European Commission not to fund research on embryos will be unlikely to change at present.
•Clinical use: somatic gene editing: There is need to understand the risks such as inaccurate editing and the potential benefit of each proposed genome modification. These applications can and should be rigorously evaluated within existing and evolving regulatory frameworks for gene and cell therapy by the European Medicines Agency and national agencies.
•Clinical use: germline interventions: These applications pose many important issues including the risks of inaccurate or incomplete editing, the difficulty of predicting harmful effects, the obligation to consider both the individual and future generations who will carry the genetic alterations, and the possibility that biological enhancements beyond prevention and treatment of disease could exacerbate social inequities or be used coercively. It would be irresponsible to proceed unless and until the relevant ethical, safety and efficacy issues have been resolved and there is broad societal consensus.
General recommendations for cross-cutting issues
•Public engagement: There has to be trust between scientists and the public and, in order to build trust, there has to be public engagement. Stakeholders, including patients, clinicians, farmers, consumers and NGOs, need to be involved in discussions about risk and benefit and scientists need to articulate the objectives for their research, potential benefits and risk management practices adopted. There is need for additional social sciences and humanities research in order to improve public engagement strategies.
•Enhancing global justice: There may be risk of increasing inequity and tension between those who have access to the benefits of genome editing applications and those who do not, although the widespread adoption of the technique might facilitate the sharing of benefits. The scientific community must work with others on the determinants to narrow the societal gap: for example, by active knowledge transfer, collaboration between researchers worldwide, open access to tools and education, and education efforts.
It is also vital for EU policy-makers to appreciate the consequences, sometimes inadvertent, of EU policy decisions on those outside the EU. There is evidence that previous decisions in the EU (for example, on GMOs) have created difficulties for scientists, farmers and politicians in developing countries. Reforming current regulatory frameworks in the EU and creating the necessary coherence between EU domestic objectives and a development agenda based on partnership and innovation is important for developing countries as well as for Europe.